1. Field of the Disclosure
The present disclosure relates to extended-release, minocycline oral dosage forms. The present disclosure further relates to a method for treating acne in a human. The present disclosure further relates to a method for assisting a physician in prescribing a dose of minocycline for the treatment of acne.
2. Description of the Related Art
Acne affects large patient populations, and is a common inflammatory skin disorder that usually localizes in sebaceous areas of the body, including on the face, back and chest.
Oral tetracycline-class antibiotics are frequently used in the treatment of acne. One oral tetracycline-class antibiotic used in the treatment of acne is minocycline hydrochloride. Oral dosage forms of minocycline hydrochloride are available commercially under various trade names.
Tetracycline-class antibiotics including minocycline hydrochloride are known to have side effects. These side effects include vestibular side effects or symptoms such as vertigo, dizziness or blurred vision. These effects are sometimes disabling. See, Gould & Brookler, Arch. Otolarang. Vol. 96, p. 291 (1972); Williams et al., Lancet, Sep. 28, 1974, p. 144-45; Fanning & Gump, Arch. Intern. Med., Vol. 136, pp. 761-62 (1976). Headache and general malaise, along with gastrointestinal symptoms such as the diarrhea, nausea, gas, or cramps, may also occur. Dry nose and dry mouth are also occasionally encountered.
Optimizing effective dosage amount of minocycline hydrochloride balanced with managing of adverse side effects in acne patients has been hampered by limited commercial availability of different strengths of dosage forms. Related applications of the assignee of the present application have disclosed the use of dosages of minocycline hydrochloride at 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg. These related applications are discussed in U.S. Ser. Nos. 11/166,817; 11/695,513; 11,695,541; 11/695,514; 12/253,845; 12/536,359; and 12/756,962 as noted above.
There exists a need for dosage forms of different strengths of minocycline hydrochloride that provide the desired extended release profile without undue side effects and also provide for more targeted dosing of 1 mg/kg/day.